934 Paclitaxel (P) and epirubicin (E) in advanced breast (ABC) and ovarian cancer (AOC): A phase I study

We have started a phase I study in ABC and AOC pts to determine the maximum tolerated dose (MTD) of P to be given with E. Up to now, 21 pts (10 MBC and II AOC) have been accrued. Patient characteristics: median age 59 y (36–71); median PS (ECOG) 0 (0–1); all MBC pts had received adjuvant chemotherapy and all AOC pts were pretreated with cisplatin regimens; 18 pts were pretreated with a cumulative E dose of 360 mg/sqm. P was given i.v. by a 3 hrs c.i. at 135 mg/sqm (9 pts); 155 mg/sqm (6 pts); 175 mg/sqm (5 pts) and 200 mg/sqm (1 pt). E was given at a fixed dose of 90 mg/sqm i.v. bolus. Courses were repeated every 21 days. All the pts have been submitted to a clinical and instrumental cardiological monitoring including: physical examination, EKG, EKG Holter, late potentials, transoesofageal electrophysiologic study, cardiac echo-doppler. 81 courses have been administered: 46 at level 1, 26 at level 2, 12 at level 3 and 1 at level 4. The main side effects was: G4 neutropenia in 57% of the courses lasting a median of 4 days (1–6). No cardiac toxicity has been observed; the median left ejection fraction was 59% at study entry and 54% after 7 courses (total cumulative dose of E = 990 mg/mq). Response rate was 62.5% in ABC and 44.4% in AOC. PE is an active regimen; the main toxicity is short-lasting neutropenia and the MTD has not yet been reached. The study is ongoing.